Repatha® (evolocumab)

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GoodRx Expands Affordable Access to Repatha® with Nearly 60% Savings
Businesswire· 2025-10-06 13:15
SANTA MONICA, Calif.--(BUSINESS WIRE)--GoodRx (Nasdaq: GDRX), the leading platform for medication savings in the U.S., today announced the availability of Repatha® (evolocumab), a cholesterol- lowering therapy, at a significantly reduced cash price. Starting today, patients can use GoodRx to access Repatha for $239 at more than 70,000 pharmacies nationwide, a savings of nearly 60% off the retail pharmacy list price. "In a healthcare system where affordability too often dictates access, GoodRx re. ...
REPATHA® NOW INDICATED FOR ADULTS AT INCREASED RISK FOR MAJOR ADVERSE CARDIOVASCULAR EVENTS DUE TO UNCONTROLLED LDL-C
Prnewswire· 2025-08-25 13:00
Core Insights - The FDA has expanded the approved use of Repatha® (evolocumab) to include adults at increased risk for major adverse cardiovascular events (MACE) due to uncontrolled low-density lipoprotein cholesterol (LDL-C), removing the previous requirement for a cardiovascular disease diagnosis [1][2] - Repatha is recognized as an effective therapy for lowering LDL-C, especially for patients who are statin-resistant or intolerant [2] - Repatha has been used by over 5 million people globally since its initial approval in 2015 [2] Company Overview - Amgen is a biotechnology company that focuses on discovering, developing, manufacturing, and delivering innovative medicines for serious diseases [10] - The company has been recognized as one of the "World's Most Innovative Companies" and is part of the Dow Jones Industrial Average and Nasdaq-100 Index [11] Product Information - Repatha is a human monoclonal antibody that inhibits PCSK9, leading to increased LDL receptors and reduced LDL-C levels [3] - The clinical safety and efficacy of Repatha have been validated through 15 years of research involving over 57,000 patients across 50 clinical trials [3] Regulatory Status - Repatha is approved in over 74 countries, including the U.S., Japan, Canada, and all EU member states, with additional applications pending in other regions [4] Safety and Efficacy - Common adverse reactions reported in clinical trials include nasopharyngitis, upper respiratory tract infections, and injection site reactions, with hypersensitivity reactions occurring in 5.1% of patients treated with Repatha [9][14] - The most common adverse reactions in the cardiovascular outcomes trial included diabetes mellitus and upper respiratory tract infections [9]
AMGEN REPORTS SECOND QUARTER 2025 FINANCIAL RESULTS
Prnewswire· 2025-08-05 20:01
Core Insights - Amgen reported strong financial performance for Q2 2025, with total revenues increasing by 9% to $9.2 billion compared to Q2 2024, driven by a 13% volume growth in product sales, despite a 3% decrease in net selling price [5][20] - The company continues to focus on innovative medicines and biosimilars, aiming for sustainable long-term growth [2] Financial Performance - Total revenues for Q2 2025 reached $9.2 billion, a 9% increase from Q2 2024 [5] - GAAP earnings per share (EPS) rose 92% from $1.38 to $2.65, while non-GAAP EPS increased 21% from $4.97 to $6.02 [5][16] - GAAP operating income increased from $1.9 billion to $2.7 billion, with an operating margin of 30.3%, up 6.6 percentage points [5][15] - Free cash flow for Q2 2025 was $1.9 billion, down from $2.2 billion in Q2 2024, influenced by deferred tax payments and higher capital expenditures [20] Product Sales Performance - Product sales grew by 9%, with 15 products achieving double-digit sales growth, including Repatha® (31% increase), EVENITY® (32% increase), and UPLIZNA® (91% increase) [5][6] - Prolia® sales decreased by 4% year-over-year to $1.1 billion, attributed to lower net selling prices [6][12] - TEZSPIRE® sales increased by 46% year-over-year to $342 million, driven by volume growth [12][13] Operating Expenses and Margins - Total operating expenses increased by 1% year-over-year, with R&D expenses rising by 21% due to investments in clinical programs [14][15] - The operating margin on a non-GAAP basis increased to 48.9%, reflecting improved operational efficiency [15][19] Cash Flow and Balance Sheet - Operating cash flow for Q2 2025 was $2.3 billion, down from $2.5 billion in Q2 2024 [18] - Cash and cash equivalents totaled $8.0 billion, while debt outstanding was $56.2 billion as of June 30, 2025 [20] Guidance - For the full year 2025, Amgen expects total revenues to be in the range of $35.0 billion to $36.0 billion [18]
AMGEN'S PHASE 2 MARITIDE DATA TO BE PRESENTED AT THE AMERICAN DIABETES ASSOCIATION 85TH SCIENTIFIC SESSIONS
Prnewswire· 2025-06-18 13:00
Core Insights - Amgen is presenting full results from the Phase 2 study of MariTide, a peptide-antibody conjugate for obesity and Type 2 diabetes, at the 85th American Diabetes Association Scientific Sessions [1][2] - The company is also sharing new data from the Phase 3 FOURIER study of Repatha® in cardiovascular disease [1] - MariTide shows promising 52-week efficacy, safety, and tolerability data, indicating robust weight loss without a plateau in patients with obesity [3][9] Company Overview - Amgen is focused on innovative medicines for serious diseases, with a strong pipeline that includes treatments for obesity and cardiovascular conditions [20][22] - The company has been recognized as one of the "World's Most Innovative Companies" and is part of the Dow Jones Industrial Average and Nasdaq-100 Index [23] Product Information - MariTide is a bispecific GLP-1 receptor agonist and GIPR antagonist, designed to provide a dual mechanism of action for weight loss and diabetes management [9] - Repatha® is a monoclonal antibody that lowers LDL cholesterol by inhibiting PCSK9, with extensive clinical trial data supporting its efficacy [13][14] Industry Context - The prevalence of obesity has more than doubled globally from 1990 to 2022, with significant health implications including increased risk for Type 2 diabetes and cardiovascular diseases [7][8] - Despite the recognition of obesity as a chronic disease, only 1%-3% of eligible adults in the U.S. receive pharmacologic treatment for weight management [8]
AMGEN REPORTS FIRST QUARTER 2025 FINANCIAL RESULTS
Prnewswire· 2025-05-01 20:01
Core Viewpoint - Amgen reported strong financial results for Q1 2025, with total revenues increasing by 9% year-over-year to $8.1 billion, driven by robust product sales and successful new product launches [2][5][22]. Financial Performance - Total revenues for Q1 2025 were $8.1 billion, a 9% increase compared to Q1 2024 [5]. - Product sales grew by 11%, primarily due to a 14% increase in volume, although this was partially offset by a 6% decrease in net selling price [5]. - GAAP earnings per share (EPS) were $3.20, a significant recovery from a loss of $0.21 in Q1 2024, influenced by an unrealized gain on equity investments [5]. - Non-GAAP EPS increased by 24% from $3.96 to $4.90, reflecting higher revenues despite increased operating expenses [5][18]. - Free cash flow for Q1 2025 was $1.0 billion, up from $0.5 billion in Q1 2024, attributed to improved business performance [22]. Product Sales Performance - Repatha® sales rose by 27% year-over-year to $656 million, driven by a 41% increase in volume [6]. - TEPEZZA® sales decreased by 10% year-over-year to $381 million, primarily due to lower volume and inventory levels [4]. - Fourteen products achieved double-digit sales growth, including Repatha®, BLINCYTO®, TEZSPIRE®, and EVENITY® [5]. - IMDELLTRA® generated $81 million in sales during its launch quarter, with positive Phase 3 trial results [5]. Operating Expenses and Margins - Total operating expenses increased by 8% year-over-year, with cost of sales as a percentage of product sales decreasing by 7.3 percentage points [18]. - GAAP operating income rose from $1.0 billion to $1.2 billion, with an operating margin increase of 1.1 percentage points to 15.0% [5][18]. - Non-GAAP operating income increased from $3.1 billion to $3.6 billion, with a non-GAAP operating margin of 45.7%, up 2.5 percentage points [5][18]. Guidance for 2025 - The company expects total revenues for 2025 to be in the range of $34.3 billion to $35.7 billion [23]. - GAAP EPS is projected to be between $12.21 and $13.46, while non-GAAP EPS is expected to range from $20.00 to $21.20 [23]. - Capital expenditures are anticipated to be approximately $2.3 billion for the year [23].